Duration of Effect of Acidform Gel on Vaginal pH

A Randomized, Placebo Controlled Pilot Study to Determine the Effect and Duration of Acidform Gel on Vaginal pH

The objective of this study was to determine the magnitude and duration of the reduction in pH (acidification) following a single dose of Acidform vaginal gel containing 3, 4, or 5 g compared with hydroxyethylcellulose placebo gel (4 g) or no treatment. Vaginal pH was measured 1 h, 6 h, 12 h, 24 h, then once daily for 7 days. In addition, the participants were assessed for an exploratory endpoint to the determine effect of one dose of Acidform gel (3, 4 or 5 g) or placebo gel (4 g) or no treatment, on asymptomatic bacterial vaginosis (BV).

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Acidform 5 g; Drug: Acidform 4 g; Drug: Acidform 3 g; Drug: Placebo 4 g

Detailed Description

One hundred healthy volunteer women, 20 per each treatment arm, were treated with either Intravaginal Acidform Gel(IVAG), 5 g dose (GROUP A), Acidform gel, 4 g dose (GROUP B), Acidform gel, 3 g dose (GROUP C), Universal Placebo Gel (UPG), 4 g (GROUP D) or no treatment (GROUP E). For GROUPS A, B, C and D, treatment is defined as speculum exam plus instillation of Investigational Product (IP) or placebo gel. For GROUP E (control), no treatment is defined as speculum exam and no gel instillation.

At least 15 women in each group were of either African American or Hispanic ethnicity. Routine screening tests were performed on admission; and subjects assessed for BV via vaginal swabs obtained for grading by Amsel criteria.

A direct vaginal pH reading by research staff- was obtained before the speculum exam, as well as one hour, and six hours post-treatment (Day 0). At the one hour and six hour post treatment time points, the direct vaginal pH readings were taken on specimens collected from two different positions in the vagina, in case of incomplete distribution of the IP soon after administration. Both readings are included as data points. At the six hour timepoint, subjects were trained on self-collecting vaginal swabs and performing the vaginal pH test. At 12 hours post-treatment, subjects performed the vaginal pH test themselves using self-obtained swabs, and record their results for clinician review.

Subjects stayed overnight in the domiciliary unit, and vaginal pH and Amsel criteria was measured again by research staff at 24 (+/- 2) hours post-treatment before discharge on Day 1. The subjects were discharged with the appropriate pH testing supplies and diary. All women agreed to abstain from sexual intercourse, douching and use of any intravaginally applied products or devices until after their final study visit on Day 7.

Subjects measured their vaginal pH at 24 (+/-2) hour intervals for 5 days (Days 2-6) as outpatients and recorded the pH test results, and any change in vaginal comfort, in a provided diary. Subjects also recorded any activities engaged in from the abstinence criteria in the study exclusion list, if applicable, each day. On Day 7, subjects returned to the clinic with their diaries, had their vaginal pH and Amsel criteria determined by the clinic staff, and queried as to any vaginal discomfort (vaginal comfort assessment) over the course of the study, as self-recorded in their diaries.

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Johns Hopkins Bayview Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44109
      • Metro Health Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Healthy female subjects between 18 and 45 years, inclusive
2. Ability to understand the consent process and procedures
3. Subjects agree to be available for all study visits
4. Written informed consent in accordance with institutional guidelines
5. Negative pregnancy test
6. Able and willing to comply with all study procedures
7. Have not engaged in sexual intercourse, douching or used of any form of vaginal suppository or intravaginal device for 24 hours prior to enrollment.
8. Agree to abstain from sexual intercourse, douching or any form of vaginal suppository or intravaginal device use during course of study
9. Report menstrual cycle regularity (25- to 35- day menstrual cycles)

Exclusion Criteria:

1. Participation in any study with an investigational compound or device within 30 days prior to signing informed consent
2. Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study protocol
3. Any other medical condition(s) that, in the judgment of the investigator, might interfere with the study or require treatment that might interfere with the study
4. Family member of the investigation study staff
5. Pregnant or breast-feeding
6. Inability to provide informed consent
7. A subject with a history or expectation of noncompliance with medications or treatment protocol
8. Women with symptoms of Urinary Tract Infection (UTI) or Sexually Transmitted Infection (STI) reported or observed during examination, at screening*.
9. Women who regularly use douches, vaginal medications or suppositories, feminine sprays, genital wipes or contraceptive spermicides, or report abnormal vaginal discharge in the past 48 hours prior to screening
10. Women who are menstruating or who would expect to menstruate during the study
11. Women who are currently using contraceptives that are directly delivered to the vaginal mucosa, such as NuvaRing
12. Any specific condition that, in the judgment of the Investigator, precludes participation because it could affect subject safety

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acidform Gel, Group A; Administration of a single vaginal dose of Acidform gel (5 g)	Drug: Acidform 5 g; Effect of 5 g vaginally administered Acidform on pH over 7 days
Experimental: Acidform Gel, Group B; Administration of a single vaginal dose of Acidform gel (4 g)	Drug: Acidform 4 g; Effect of 4 g vaginally administered Acidform on pH over 7 days
Experimental: Acidform Gel, Group C; Administration of a single vaginal dose of Acidform gel (3 g)	Drug: Acidform 3 g; Effect of 3 g vaginally administered Acidform on pH over 7 days
Placebo Comparator: Placebo Gel, Group D; Administration of a single dose of hydroxyethylcellulose (HEC) placebo gel (4 g)	Drug: Placebo 4 g; Effect of 4 g of vaginally administered HEC placebo gel on pH over 7 days; Other Names: Natrasol 250 HX Pharm
No Intervention: No intervention, Group E; No vaginal product administered

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Vaginal pH Following a Single Dose of Acidform (3, 4, and 5 g), HEC Placebo (4 g), or no Intervention.	Vaginal swabs were used to collect samples from the vagina of women dosed with Acidform, HEC placebo, or no treatment. The pH of the samples was measured at pre-determined time points over the course of 7 days.	Baseline (Day 0), 1, 6 & 12 hours post treatment, and Days 1, 2, 3, 4, 5, 6 & 7.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Effect of a Single Dose of Acidform Gel (3, 4 or 5 g), Placebo Gel (4 g), or no Treatment on Asymptomatic Bacterial Vaginosis (BV) Based on Amsel Criteria.	Amsel Criteria was used at baseline (day 0), compared to Day1 and Day 7 following the single dose of Acidform or placebo. Amsel criteria assessments consisted of Yes/No indications for the presence of each of the following: Vaginal pH> 4.5; Presence of thin, grayish white vaginal discharge; Positive wet prep; Positive whiff amine test. Based on the individual criteria, a derived overall result (positive/negative) was reported. Amsel Result was automatically calculated based whether or not subject is positive in three of the four criteria listed above.	Baseline (Day 0), Day 1 and Day 7

Collaborators and Investigators

• Sponsor: Evofem Inc.
• Collaborators: Johns Hopkins University; MetroHealth Medical Center; Clinical Research Management, Inc.
• Investigators: Principal Investigator: Ann Avery, MD, Metro Health Medical Center; Principal Investigator: Seema Nayak, MD, Johns Hopkins University; Study Director: John M Griffiss, MD, Clinical Research Management, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2016
• Primary Completion (Actual): December 12, 2016
• Study Completion (Actual): December 12, 2016

Study Registration Dates

• First Submitted: February 18, 2016
• First Submitted That Met QC Criteria: February 25, 2016
• First Posted (Estimate): February 26, 2016

Study Record Updates

• Last Update Posted (Actual): November 20, 2020
• Last Update Submitted That Met QC Criteria: October 29, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: EVO-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED